K-number	K172128
Device name	EsoFLIP® ES-310 Balloon Catheter
Applicant	Crospon, Ltd.
Product code	PIE
Device class	Class II
Decision date	Nov 22, 2017
Decision	Substantially Equivalent
Regulation	876.5980

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Source

View the full FDA submission: accessdata.fda.gov

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EsoFLIP® ES-310 Balloon Catheter

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